CTEP Branches and Offices
Childhood Cancer Resources
- Pediatric Clinical Trials Cooperative Groups and Consortia
- Pediatric Preclinical in Vivo Testing (PIVOT) Program
- Information Regarding the Inclusion and Protection of Children Enrolled on
Federally-supported Clinical Trials - Videos to Support Parents Whose Child Has Cancer
- FDA Pediatric Resources
- Reports from CTEP-Sponsored Childhood Cancer Meetings
Pediatric Clinical Trials Cooperative Groups and Consortia
Children’s Oncology Group
The Children’s Oncology Group (C.O.G.) is supported by the National Cancer Institute to conduct clinical trials devoted exclusively to children and adolescents with cancer. C.O.G. develops and coordinates cancer clinical trials conducted at its more than 200 member institutions, which include cancer centers of all major universities and teaching hospitals throughout the U.S. and Canada, as well as sites in Europe and Australia. C.O.G. members include over 5000 cancer researchers dedicated to saving the lives of children with cancer. C.O.G. was formed by the merger of the four previous children’s cancer cooperative groups (CCG, POG, IRSG, NWTSG) in order to accelerate the search for a cure for the cancers of children. Through the C.O.G. network of member institutions, children with cancer, regardless of where they live, can access state-of-the art therapies and the collective expertise of world-renowned pediatric specialists.
Pediatric Early Phase Clinical Trials Network (PEP-CTN)
The Pediatric Early Phase Clinical Trials Network (PEP-CTN), which builds upon the success of the Children's Oncology Group (COG) Phase 1 & Pilot Consortium, conducts "first in children" early phase clinical trials of new agents that are relevant to one or more childhood cancers. In addition, the PEP-CTN conducts pilot studies of novel agents/regimens to determine their tolerability so that promising regimens can proceed to definitive testing in phase 3 clinical trials. The PEP-CTN includes 21 core member institutions, representing many of the leading US childhood cancer centers. The PEP-CTN Operations and Data/Statistics Center (ODSC) is embedded within the COG Operations and Data/Statistics center. Candidate agents for PEP-CTN evaluation are reviewed by the PEP-CTN Agent Prioritization Committee, which provides timely, rigorous, and transparent prioritization of investigational agents for evaluation through the PEP-CTN. Agents prioritized by the PEP-CTN Agent Prioritization Committee have protocols rapidly developed by the PEP-CTN.
Pediatric Brain Tumor Consortium (PBTC)
The primary objective of the PBTC is to rapidly conduct phase 1 and 2 clinical evaluations of new therapeutic drugs, intrathecal agents, delivery technologies, biological therapies, and radiation treatment strategies in children age 0 – 21 years of age with primary CNS tumors. The PBTC includes nine leading academic institutions with extensive experience in the design and conduct of childhood cancer clinical trials for children with brain tumors. Another objective of the PBTC is to develop and coordinate innovative neuroimaging techniques on a consortium-wide basis. Results from PBTC studies will be available to large international collaborative groups for confirmatory phase 2 and multiagent phase 3 clinical trials. Specifically, direct interactions have been established with the Children's Oncology Group. This collaborative interaction assures a rapid transition from phase 1 and 2 trials conducted by the PBTC.
New Approaches to Neuroblastoma Therapy Consortium
NANT is a consortium of University and Children’s Hospitals funded by the NCI to test promising new therapies for neuroblastoma. NANT members constitute a group of closely collaborating investigators who are linked with laboratory programs developing novel therapies for high-risk neuroblastoma. The group conducts limited-institution clinical trials to test new drugs and new combinations of drugs against high-risk neuroblastoma with the goal that promising therapies can be tested nationally.
Childhood Cancer Survivor Study: An Overview
In 2016, it was estimated that there were 15.5 million cancer survivors in the United States. As of 2015, at least 429,000 of these survivors were first diagnosed when they were under the age of 20. Advances in cancer treatment mean that today 84 percent of children diagnosed with cancer are alive at least five years after diagnosis. Many ultimately will be considered cured. As a consequence, interest is growing in the long-term health of these survivors.
Health problems that develop years later because of a cancer treatment are known as late effects. (For more information, see Late Effects of Treatment for Childhood Cancer.) The Childhood Cancer Survivor Study, funded by the National Cancer Institute and other organizations, was started in 1994 to better understand these late effects, increase survival, and minimize harmful health effects. More...
Information regarding the inclusion and protection of children enrolled on Federally supported clinical trials
- Federal Policy for the Protection of Human Subjects
45 Code of Federal Regulations 46
https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html - Subpart D-Additional DHHS Protections for Children Involved as Subjects in Research
https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/common-rule-subpart-d/index.html
https://www.hhs.gov/ohrp/regulations-and-policy/guidance/special-protections-for-children/index.html - NIH policy and guidelines on the inclusion of children as participants in research involving human subjects
https://grants.nih.gov/policy/inclusion/lifespan.htm - Summary: Additional Safeguards for Children in Clinical Investigation of FDA-Regulated Products
https://www.fda.gov/about-fda/economic-impact-analyses-fda-regulations/summary-additional-safeguards-children-clinical-investigation-fda-regulated-products
FDA Pediatric Resources
The FDA Office of Pediatric Therapeutics web site has a wide range of information relevant to clinical research involving children, including information on guidance documents and regulations related to pediatric drug development.
Reports from CTEP-Sponsored
Childhood Cancer Meetings
- Report of the Phase 2 Window Meeting (July 22, 1997)